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Carboplatin as a Radiosensitizing Agent in Locally Advanced Head and Neck Cancer: Friendly to an Older Veteran Population
Background
The standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is combination chemoradiotherapy. Platinum-based chemotherapy is used for radiosensitization and significantly improves locoregional control and survival. Cisplatin is the standard of care; however, many patients are cisplatin-ineligible due to underlying comorbidities. Carboplatin is an alternative chemotherapy in these patients, but efficacy data are lacking. Purpose: To evaluate the efficacy and tolerability of weekly carboplatin concurrent with radiation in veterans with locally advanced HNSCC.
Methods
Our tumor registry was used to identify patients who received platinum-based chemoradiotherapy for stage III-IVB HNSCC at a single center between 2007 to 2017. Patients who received carboplatin were identified. Data including dosing, toxicities, and disease response was collected and analyzed.
Results
A total of 26 patients who received weekly carboplatin were analyzed. All patients were male with an average age of 65. A usual dose of carboplatin AUC 2 was utilized. The average cumulative dose for weekly carboplatin was AUC 12, with most patients (65%) receiving 6 doses or more. The mean number of weekly carboplatin doses held was 0.3. 7 patients (27%) had at least one dose held. 21 (81%) patients showed treatment benefit: 19 (73%) had complete response and 2 (8%) had partial response on first scan following treatment. The four most common toxicities were mucositis (69%), nausea/vomiting (23%), oral thrush (19%), and dermatologic toxicities (19%). The most common toxicities causing dose interruption were fatigue (12%), neutropenia (8%), and thrombocytopenia (8%). Grade 3/4 mucositis was experienced in 6 patients (23%). Other grade 3/4 toxicities included neutropenia (8%), anemia (8%), thrombocytopenia (1%), nephrotoxicity (1%) and nausea (1%).
Conclusions
Carboplatin was both efficacious and well tolerated in our older veteran population. These findings add to the limited body of evidence examining weekly carboplatin in patients with advanced head and neck cancer. While cisplatin remains standard of care, carboplatin may be a reasonable alternative as evidenced in a real-world veteran population.
Background
The standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is combination chemoradiotherapy. Platinum-based chemotherapy is used for radiosensitization and significantly improves locoregional control and survival. Cisplatin is the standard of care; however, many patients are cisplatin-ineligible due to underlying comorbidities. Carboplatin is an alternative chemotherapy in these patients, but efficacy data are lacking. Purpose: To evaluate the efficacy and tolerability of weekly carboplatin concurrent with radiation in veterans with locally advanced HNSCC.
Methods
Our tumor registry was used to identify patients who received platinum-based chemoradiotherapy for stage III-IVB HNSCC at a single center between 2007 to 2017. Patients who received carboplatin were identified. Data including dosing, toxicities, and disease response was collected and analyzed.
Results
A total of 26 patients who received weekly carboplatin were analyzed. All patients were male with an average age of 65. A usual dose of carboplatin AUC 2 was utilized. The average cumulative dose for weekly carboplatin was AUC 12, with most patients (65%) receiving 6 doses or more. The mean number of weekly carboplatin doses held was 0.3. 7 patients (27%) had at least one dose held. 21 (81%) patients showed treatment benefit: 19 (73%) had complete response and 2 (8%) had partial response on first scan following treatment. The four most common toxicities were mucositis (69%), nausea/vomiting (23%), oral thrush (19%), and dermatologic toxicities (19%). The most common toxicities causing dose interruption were fatigue (12%), neutropenia (8%), and thrombocytopenia (8%). Grade 3/4 mucositis was experienced in 6 patients (23%). Other grade 3/4 toxicities included neutropenia (8%), anemia (8%), thrombocytopenia (1%), nephrotoxicity (1%) and nausea (1%).
Conclusions
Carboplatin was both efficacious and well tolerated in our older veteran population. These findings add to the limited body of evidence examining weekly carboplatin in patients with advanced head and neck cancer. While cisplatin remains standard of care, carboplatin may be a reasonable alternative as evidenced in a real-world veteran population.
Background
The standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is combination chemoradiotherapy. Platinum-based chemotherapy is used for radiosensitization and significantly improves locoregional control and survival. Cisplatin is the standard of care; however, many patients are cisplatin-ineligible due to underlying comorbidities. Carboplatin is an alternative chemotherapy in these patients, but efficacy data are lacking. Purpose: To evaluate the efficacy and tolerability of weekly carboplatin concurrent with radiation in veterans with locally advanced HNSCC.
Methods
Our tumor registry was used to identify patients who received platinum-based chemoradiotherapy for stage III-IVB HNSCC at a single center between 2007 to 2017. Patients who received carboplatin were identified. Data including dosing, toxicities, and disease response was collected and analyzed.
Results
A total of 26 patients who received weekly carboplatin were analyzed. All patients were male with an average age of 65. A usual dose of carboplatin AUC 2 was utilized. The average cumulative dose for weekly carboplatin was AUC 12, with most patients (65%) receiving 6 doses or more. The mean number of weekly carboplatin doses held was 0.3. 7 patients (27%) had at least one dose held. 21 (81%) patients showed treatment benefit: 19 (73%) had complete response and 2 (8%) had partial response on first scan following treatment. The four most common toxicities were mucositis (69%), nausea/vomiting (23%), oral thrush (19%), and dermatologic toxicities (19%). The most common toxicities causing dose interruption were fatigue (12%), neutropenia (8%), and thrombocytopenia (8%). Grade 3/4 mucositis was experienced in 6 patients (23%). Other grade 3/4 toxicities included neutropenia (8%), anemia (8%), thrombocytopenia (1%), nephrotoxicity (1%) and nausea (1%).
Conclusions
Carboplatin was both efficacious and well tolerated in our older veteran population. These findings add to the limited body of evidence examining weekly carboplatin in patients with advanced head and neck cancer. While cisplatin remains standard of care, carboplatin may be a reasonable alternative as evidenced in a real-world veteran population.
How to Make Keeping Up With the Drugs as Easy as Keeping Up With the Kardashians: Implementing a Local Oncology Drug Review Committee
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Background
From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.
Methods
DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.
Results
Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).
Conclusions
DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.
Implementation of Electronic Antineoplastic Ordering Templates in a Veterans Health System
BACKGROUND: Antineoplastic ordering is high in both complexity and risk for medication errors. Joint Commission and institutional policy recommends computerized prescriber order entry and verification by a pharmacist as a best practice for patient safety. The use of ordering templates minimizes the risk of errors and ensures appropriate supportive care is being provided. The Veterans Affairs electronic medical record does not feature an antineoplastic ordering component; historically, templates have been on paper. The oncology, pharmacy, and clinical informatics departments in our health system formed a team to create electronic antineoplastic ordering templates.
PURPOSE: To evaluate the impact of electronic antineoplastic ordering templates on pharmacy and infusion clinic efficiency and pharmacist interventions.
METHODS: Ordering templates, which included standard dosing and supportive care medications, were developed and activated for prescribers in phases over the course of two years. Immunotherapy and oral oncolytic templates were activated initially, followed by full implementation of the majority of intravenous (IV) ordering templates. Percent of electronic antineoplastic orders, pharmacy processing time, time to first drug delivery, and number of pharmacist encounters and interventions were documented daily for four weeks after initial implementation and for ten weeks after full implementation. Means were compared using unpaired t tests.
RESULTS: After initial implementation, the percentage of electronic antineoplastic orders increased from 0% to 100% for oral antineoplastics and from 0% to 39% for IV orders. After full implementation, IV orders increased to 69% in weeks 1-5 and 96% in weeks 6-10. Mean pharmacy processing time for supportive care medications was 35 minutes initially. This increased briefly after full implementation (weeks 1-5), then decreased to 17 minutes in weeks 6-10 (p<0.01). Delivery of the first medication to the infusion center decreased by 31 minutes at week ten (<0.01). Mean daily pharmacist encounters increased by 28%(<0.01) and documented interventions increased by 22% (<0.01).
IMPLICATIONS: Implementation of electronic antineoplastic ordering templates increased provider order entry, pharmacy and infusion clinic efficiency and pharmacist interventions. These outcomes may translate to improved patient safety and patient access to quality care. Templates developed can serve as a model for other health systems to implement electronic antineoplastic ordering.
BACKGROUND: Antineoplastic ordering is high in both complexity and risk for medication errors. Joint Commission and institutional policy recommends computerized prescriber order entry and verification by a pharmacist as a best practice for patient safety. The use of ordering templates minimizes the risk of errors and ensures appropriate supportive care is being provided. The Veterans Affairs electronic medical record does not feature an antineoplastic ordering component; historically, templates have been on paper. The oncology, pharmacy, and clinical informatics departments in our health system formed a team to create electronic antineoplastic ordering templates.
PURPOSE: To evaluate the impact of electronic antineoplastic ordering templates on pharmacy and infusion clinic efficiency and pharmacist interventions.
METHODS: Ordering templates, which included standard dosing and supportive care medications, were developed and activated for prescribers in phases over the course of two years. Immunotherapy and oral oncolytic templates were activated initially, followed by full implementation of the majority of intravenous (IV) ordering templates. Percent of electronic antineoplastic orders, pharmacy processing time, time to first drug delivery, and number of pharmacist encounters and interventions were documented daily for four weeks after initial implementation and for ten weeks after full implementation. Means were compared using unpaired t tests.
RESULTS: After initial implementation, the percentage of electronic antineoplastic orders increased from 0% to 100% for oral antineoplastics and from 0% to 39% for IV orders. After full implementation, IV orders increased to 69% in weeks 1-5 and 96% in weeks 6-10. Mean pharmacy processing time for supportive care medications was 35 minutes initially. This increased briefly after full implementation (weeks 1-5), then decreased to 17 minutes in weeks 6-10 (p<0.01). Delivery of the first medication to the infusion center decreased by 31 minutes at week ten (<0.01). Mean daily pharmacist encounters increased by 28%(<0.01) and documented interventions increased by 22% (<0.01).
IMPLICATIONS: Implementation of electronic antineoplastic ordering templates increased provider order entry, pharmacy and infusion clinic efficiency and pharmacist interventions. These outcomes may translate to improved patient safety and patient access to quality care. Templates developed can serve as a model for other health systems to implement electronic antineoplastic ordering.
BACKGROUND: Antineoplastic ordering is high in both complexity and risk for medication errors. Joint Commission and institutional policy recommends computerized prescriber order entry and verification by a pharmacist as a best practice for patient safety. The use of ordering templates minimizes the risk of errors and ensures appropriate supportive care is being provided. The Veterans Affairs electronic medical record does not feature an antineoplastic ordering component; historically, templates have been on paper. The oncology, pharmacy, and clinical informatics departments in our health system formed a team to create electronic antineoplastic ordering templates.
PURPOSE: To evaluate the impact of electronic antineoplastic ordering templates on pharmacy and infusion clinic efficiency and pharmacist interventions.
METHODS: Ordering templates, which included standard dosing and supportive care medications, were developed and activated for prescribers in phases over the course of two years. Immunotherapy and oral oncolytic templates were activated initially, followed by full implementation of the majority of intravenous (IV) ordering templates. Percent of electronic antineoplastic orders, pharmacy processing time, time to first drug delivery, and number of pharmacist encounters and interventions were documented daily for four weeks after initial implementation and for ten weeks after full implementation. Means were compared using unpaired t tests.
RESULTS: After initial implementation, the percentage of electronic antineoplastic orders increased from 0% to 100% for oral antineoplastics and from 0% to 39% for IV orders. After full implementation, IV orders increased to 69% in weeks 1-5 and 96% in weeks 6-10. Mean pharmacy processing time for supportive care medications was 35 minutes initially. This increased briefly after full implementation (weeks 1-5), then decreased to 17 minutes in weeks 6-10 (p<0.01). Delivery of the first medication to the infusion center decreased by 31 minutes at week ten (<0.01). Mean daily pharmacist encounters increased by 28%(<0.01) and documented interventions increased by 22% (<0.01).
IMPLICATIONS: Implementation of electronic antineoplastic ordering templates increased provider order entry, pharmacy and infusion clinic efficiency and pharmacist interventions. These outcomes may translate to improved patient safety and patient access to quality care. Templates developed can serve as a model for other health systems to implement electronic antineoplastic ordering.